Kornimate/medical-research-clean huggingface dataset:
metformin sr tablet (dulening) and glucophage in patients with type 2 diabetes

Conditions: Diabetes Mellitus

Summary: metformin hydrochloride sustained-release tablets made in conquer pharmaceutical co., ltd is approved by china food and drug administration (cfda). whether its efficacy and safety are equal to glucophage is unclear.

to perform a rct for the comparison between metformin hydrochloride sustained-release tablets made in conquer pharmaceutical co., ltd and glucophage .

Eligibility criteria:
inclusion criteria: 1. well informed of the procedures of this trial and informed consent is obtained 2. voluntarily accept standardized treatment 3.18-75 years old, gender is not limited 4.newly diagnosed as type 2 diabetes and have not yet received any hypoglycemic therapy 5.unable to control the blood glucose by diet and exercise: 7.5% ≤hba1c ≤11.0%, in screening and before randomization 6.bmi: 19\~35 kg/m2 7.well compliance 8.capable of self blood glucose monitoring exclusion criteria: 1. pregnant or lactating 2. type 1 diabetes 3. poor blood glucose control（hba1c\>11%） 4. a history of malignant tumor 5. abnormal liver or renal function (defined as alanine aminotransferase(alt)\>2.5 times higher than normal range,or egfr\<45 ml/min per 1•73 m²) 6. poor blood pressure control \[systolic blood pressure(sbp)\>180mmhg,or diastolic blood pressure(dbp)\>110mmhg\] 7. with severe heart disease,cardiac function worse than grade ii,anemia(hb\<9.0g/d1) 8. continuous use of antidiabetic drugs more than one week in recent 3 months 9. history of acute metabolic complications in recent 6 months 10. blood routine test indicates that the white blood cell count(wbc) \<3\*109/l 11. body mass index(bmi)\<18.5 or ≥35kg/m2 12. drug or alcohol abuse 13. accompanying mental disorder who can't collaborate 14. abnormal digestion and absorption function 15. other endocrine diseases 16. other chronic diseases needed long-term glucocorticoid treatment 17. with severe infection, immune dysfunction 18. a history of metformin allergies or allergic constitution
psychiatric disorders in child and adolescent offspring of parents with schizophrenia and bipolar disorders.

Conditions: Mood Disorders; Schizophrenia Disorders

Summary: offspring of parents with bipolar disorder (bd) and schizophrenia (sz) are vulnerable and at high risk for these disorders. despite the fact that positive family history of sz or bd is the strongest predictor for the development of these severe mental illnesses, there is limited evidence assessing young adults of sz and bp simultaneously with lack of detailed handling of similarities in risk and developmental trajectories during adolescence

offspring of parents with bipolar disorder (bd) and schizophrenia (sz) are vulnerable and at high risk for these disorders. despite the fact that positive family history of sz or bd is the strongest predictor for the development of these severe mental illnesses, there is limited evidence assessing young adults of sz and bp simultaneously with lack of detailed handling of similarities in risk and developmental trajectories during adolescence \[1, 2\]. sz and bp are thought to share a common pathophysiological basis due to advances in the field of molecular genetics, which have yielded overlapping findings between the two disorders \[3, 4\]. the psychopathological base during adolescence is influenced by neurodevelopmental deviation prior to clinical onset of many severe mental illnesses \[5, 6\]. moreover, the risk for developing psychopathology is high during adolescence and prodromal symptoms start even earlier and may overlap and are difficult to differentiate \[5-8\]. this has turned efforts towards identification and treatment of individuals at early stages of the illness, when first clinical manifestations emerge \[8, 9\]. importantly, subthreshold symptoms of mania and depression along with unspecific behavioural, emotional, and cognitive manifestations are highly predictive of future manic and depressive episodes in bd as well as anxiety disorders, which is confirmed by the clinical staging perspective \[10, 11\]. nevertheless, early recognition and intervention during the prodromal phase is still at an early stage in sz \[12\] with limited research into valid prodromal criteria for bp \[13\]. retrospective studies combining subjects with early-onset mania and early-onset first-episode psychosis have reported a similar pattern of neurodevelopmental and psychopathological features predating the appearance of more specific prodromal symptoms in both disorders \[14, 15\]. therefore, the substantial overlap of symptoms in the initial phases suggests that early identification programmes should be aimed at detecting both the pre-psychotic and the pre-manic phases of sz and bp \[16\]

Eligibility criteria:
inclusion criteria: - 6_18 years iq \> 70 parents of schizophrenia \& mood disorders . exclusion criteria: * age \ 18 iq \< 70 .

Keywords: bipolar schizophrenia
laser ablation for intermediate and advanced hepatocellular carcinoma with portal vein tumor thrombus

Conditions: Hepatocellular Carcinoma; Laser Ablation; Portal Vein Tumor Thrombus

Summary: hepatocellular carcinoma (hcc) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. liver resection is the first-line curative treatment for huge hcc. the 5-year overall survival (os) rates after hepatic resection were range from 25% to 45% and the incidence of portal vein tumor thrombus (pvtt) for intermediate and advanced hepatocellular carcinoma patients were as high as 60%-90%. at present, there is no effective treatment for patients with pvtt. laser ablation (la) showed a good performance in eliminating the pvtt and the three-dimensional conformal radiotherapy (3d-crt) with γ ray (γ-knife) can also be used to treat patients with pvtt. but there still lack of evidence-based research to compare the clinical outcome of 3d-crt with γ ray and la. in view of this, we aim to implement a randomized controlled study to find out an effective treatment for intermediate and advanced hepatocellular carcinoma patients with pvtt based on evidence-based research.


Eligibility criteria:
inclusion criteria: 1. child-pugh class b liver function； 2. preoperative ecog criteria score of 0-2; 3. patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (ct) and/or magnetic resonance imaging (mri); 4. tumor thrombus in the second-order or more peripheral branch of portal vein; 5. tumor number ≤5 and the sum of largests tumor diameter ≤15 cm; 6. the expected survival time \>6 months. exclusion criteria: 1. other anticancer treatment before treatment 2. patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer 3. patients with other diseases that may affect the treatment of this treatment 4. history of other malignant tumors 5. patients who are participating in other clinical trials 6. pregnant, lactating women

Keywords: laser ablation portal vein tumor thrombus
egb 761® (tanakan®) effectiveness in the treatment of patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders

Conditions: Cognitive Disorders

Summary: the purpose of this study is to determine the effectiveness of egb 761® (tanakan®) in russian patients of middle age and younger, suffering from psycho-emotional symptoms added to cognitive disorders based on the improvement of fam test (feeling-healthy, activity, mood test) score.


Eligibility criteria:
inclusion criteria: * patients who signed the informed consent for participation in the observational study before collection of any information * patients who complain of psycho-emotional disturbance (of any intensity) * men and women aged 18-45 years, who prescribed to receive tanakan® for cognitive disorders exclusion criteria: * presence of any contraindications listed in the tanakan® local smpc (hypersensitivity to any of the components of tanakan®, pregnancy, lactation, erosive gastritis in acute phase, gastric ulcer and duodenum ulcer in acute phase, acute cerebrovascular accident, acute myocardial infarction, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption, haemolysis) * presence of dementia (according to diagnostic and statistical manual of mental disorders \[dsm iv\]) * disturbance of usual activities of daily living (e.g. self-care) * patients taking antipsychotic drugs, antidepressants, tranquillisers and nootropic agents * presence of any severe disease or condition which could affect cognitive function (e.g. parkinson disease, epilepsy, brain inflammatory disease, major depression, recent post-stroke condition, recent brain-trauma etc.); * presence of anxiety or depression according to the hospital anxiety and depression scale (11 points and more).

Keywords: psycho-emotional symptoms
a study to evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia

Conditions: Schizophrenia

Summary: clozapine is an antipsychotic. this 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia. this study is not recruiting in the united states.

clozapine is an antipsychotic. this 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.

Eligibility criteria:
inclusion criteria: * diagnosed as schizophrenia * not responded to at least two atypical antipshychotics launched in japan * inpatient exclusion criteria: * low white blood cell count * significant heart diseases * diabetes mellitus other protocol-defined exclusion criteria may apply.

Keywords: schizophrenia, treatment-resistant, clozapine
comparison of novo rapid 30 mix injection flexpen® and humalog 25 mix injection kwikpen® in type 2 diabetic patients

Conditions: Diabetes Complications; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to investigate patient's usability, preference and blood glucose control for the new prefilled disposable insulin lispro mixture (humalog mix 25 injection kwikpen®). for that purpose, randomized open-label, 2-period direct comparative crossover study is planned in comparison with insulin aspart mixture (novo rapid 30 mix injection flexpen®).

* concomitant drugs the treatment with other insulin preparation is prohibited during the study period. as to the drugs except insulin that have been used for the treatment of diabetes and its complication since the time before the study, the content should not be changed during the study in principle unless the complication is cured. if any new complication occurs during the study period, an appropriate treatment is given by the judgment of investigator. * compliance with treatment method the investigator gives sufficient explanation on the following contents to the patient. * to inject the prescribed volume of insulin at the prescribed time. * to observe the appointed date for the next visit. * termination of assessment the study is discontinued if any of the following events occurs after the start of study. * important protocol violation * when continued treatment is judged difficult due to the onset of an adverse event * death * when the follow-up of patient becomes impossible * other than the above, when the investigator judges it necessary to discontinue the study

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients * patients who have used humalog mix 25 injection kwikpen® or novo rapid 30 mix injection flexpen® for 3 months or more. * outpatients regularly visiting hospital * patients 20 years old or older but under 80 years old (gender is disregarded) exclusion criteria: * patients with a serious complication in the heart, liver or kidney * pregnant or possibly pregnant patients, or lactating patients * patients complicated with a malignant tumor at present. * patients allergic to insulin analog preparations. * patients taking an illegal drug. * patients participating in other clinical study. * other than the above, patients judged inappropriate as the subjects of this study by the investigator
efficacy of palatinose™ versus sucrose on flow mediated dilation in healthy subjects with mild hypertension

Conditions: Overweight and Obesity

Summary: to determine the efficacy of palatinose versus sucrose on flow mediated dilation (fmd) in healthy subjects with mild hypertension.


Eligibility criteria:
inclusion criteria: * subject is healthy at the time of pre-examination * subject has a bmi of 25 - 35 kg/m² * subject is aged 25 - 50 years at the time of pre-examination * signed written informed consent * inactive (ipaq score \<1) * waist to hip ratio ≥0.90 cm for males, ≥0.85 cm for females * high-normo/mild hypertensive (sbp: 130-159 mmhg / dbp: 80-99 mmhg) exclusion criteria: * use of medication interfering with raas, such as ace-inhibitors, * advanced cardio-vascular disease (cvd), * severe kidney disorders (ckd), * diabetes mellitus, both type 1 and ii diabetes, * pregnant, lactating or wish to become pregnant, * hypersensitivity to any of the components of the test product, * restricted diet (vegetarian) * thyroid disease * heavy smokers (light smokers allowed) * lack of suitability for participation in the trial, for any medical reason, as judged by the pi. * excessive alcohol consumption (\>21 units/week for males \& \>14 units/week for females)

Keywords: glycemic index overweight endothelial function carbohydrate
lateral epicondylitis continuous radiofrequency microtenotomy

Conditions: Tennis Elbow

Summary: prospective study measuring the outcome of continuous radio frequency 60 degree on lateral epicondylitis not responding to traditional ultrasound guided injection


Eligibility criteria:
inclusion criteria: * chronic tennis elbow no response to traditional injection ultrasound exam reveal swelling of common extensor tendon exclusion criteria: * complete tear of common extensor tendon implanted pace maker
vitamin d and calcium homeostasis for prevention of type 2 diabetes

Conditions: Glucose Intolerance; Type 2 Diabetes Mellitus; Metabolic Syndrome

Summary: the purpose of the randomized trial is to quantify the effect of vitamin d and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.

there is animal and human observational evidence to suggest that vitamin d and calcium are important in modifying t2dm risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2dm and potential mechanisms in humans. we are conducting a randomized trial to quantify the effect of vitamin d and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2dm. we anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2dm. based on the results of the proposed studies and future work in this area, vitamin d and calcium supplementation can assume an important role in the treatment of t2dm and in the prevention of the disease in the 41 million americans who are at risk of developing t2dm.

Eligibility criteria:
inclusion criteria: * ethnicity: all ethnic groups * gender: men and women * age 1. lower age limit: 40 years inclusive 2. upper age limit: none * bmi 1. lower bmi limit: 25 inclusive 2. upper bmi limit: 40 inclusive * glucose intolerance / mild diabetes defined as 1. fasting glucose ≥100 mg/dl or 2. 2-hr glucose after ogtt ≥140 mg/dl or 3. 5.8 ≤ hemoglobin a1c ≤ 7 major exclusion criteria: * diabetes requiring pharmacotherapy * smoking * hyperparathyroidism * hypercalcemia (calcium \> 10.5 mg/dl) * kidney stone * pregnancy

Keywords: glucose intolerance type 2 diabetes mellitus metabolic syndrome
pericapsular exparel for pain relief in bunionectomy and related procedures

Conditions: Bunion; Hallux Rigidus

Summary: exparel is an fda-approved local anesthetic (bupivacaine), in a long-release formulation. in this study the investigators plan to determine the ability of exparel to control post-operative pain in common first metatarsophalangeal (mtp) joint procedures (bunion surgery, 1st mtp fusion, and cheilectomy).

the investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (mtp) joint procedure (bunionectomy, 1st mtp fusion, or cheilectomy). as a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). patients are then given prescriptions for oral opioids to manage post-operative pain. the purpose of this study is to determine whether a single intrapopliteal administration of exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * undergoing distal or midshaft osteotomy for bunion correction, 1st mtp fusion, or cheilectomy exclusion criteria: * age less than 18 * unable to read/write english * dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting * weight \<70 kg * allergy to local anesthetics * history of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of percocet 5/325 mg) regularly for approximately 7 days or more or who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation) * any history of opioid misuse, illicit or prescription * prior mtp joint correction on the surgical limb * midfoot and hindfoot procedures performed concurrently, on the same day * pregnant or breastfeeding

Keywords: exparel bupivacaine hallux valgus deformity bunionectomy
safety and efficacy of a low dose naloxone infusion in nicu patients

Conditions: Opioid Tolerance; Pain

Summary: when narcotic pain medicine, like fentanyl or morphine, is given to adults and children for several days, they often develop a tolerance to the medicine. this means they may need higher doses over time to get the same amount of pain control. when it is time to stop the medicine, the dose has to be decreased slowly so that the patient does not have withdrawal symptoms. naloxone is a medicine that at high doses can reverse the effects of narcotics. at very small doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. this could mean less narcotic pain medicine is needed over fewer days. the purpose of this research study is to see if giving naloxone to neonates who require narcotic infusions is safe and effective. safety will be measured by the incidence of side effects. efficacy will be measured by monitoring for changes in pain and sedation scores and need for more pain medicine.

this is a prospective, non-randomized, single center, open label dose escalation study. we hypothesize that critically ill patients in the nicu may benefit from a low dose naloxone infusion resulting in decreased tolerance, less severe withdrawal symptoms, lower cumulative doses of opiates, and fewer total days of opiates, all while maintaining adequate or enhanced pain control and sedation. establishing safety and efficacy data for this potentially beneficial therapy is an important first step towards using this therapy to decrease the risk of opioid tolerance and withdrawal in this population of infants.

Eligibility criteria:
inclusion criteria: * neonates \> 36 0/7 weeks estimated gestational age * less than 30 days of life * requiring admission to to the neonatal intensive care unit * requiring continuous infusions of fentanyl or morphine analgesia * anticipated to require opioid infusions for at least four days * patients must be enrolled within 120 hours of initiating opioid infusions * all patients will also require mechanical ventilation prior to study entry. exclusion criteria: * preterm infants \< 36 weeks gestation * neonates with major neurologic anomalies, seizures * opioid infusion administration for \> 120 hours prior to study entry * patients requiring ecmo support prior to study entry * neonates born to mothers who are known to be opioid dependent

Keywords: naloxone neonate pain
knee osteoarthritis disabling pain program for the brazilian unified health system

Conditions: Osteoarthritis, Knee

Summary: this is a randomized clinical trial to compare two interventions for reducing knee pain and improving knee function of patients with knee osteoarthritis. sixty participants will be randomly allocated to one of the intervention groups, either a knee educational program or a combination of knee educational program and medical interventions. participants will be assessed primarily on function and pain, as well as other secondary outcomes at baseline, at the end of the interventions, and three months after the end of the interventions.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee osteoarthritis; * moderate to severe knee pain (vas \>= 4); * knee pain for at least 3 months prior to inclusion; * willing to sign the informed consent form. exclusion criteria: * untreated severe psychological or psychiatric diseases without treatment; * presence of fibromyalgia; * presence of systemic inflammatory rheumatic diseases; * presence of neoplasia; * presence of relevant pain in other joints, according to medical evaluation; * presence of intolerance or allergy to lidocaine or local anaesthetics; * concomitant use of anticoagulant drug.

Keywords: physical and rehabilitation medicine knee osteoarthritis pain
amnesia after surgery for anterior communicating aneurysm： high resolution magnetic resonance (mr) imaging findings

Conditions: Subarachnoid Hemorrhage; Cerebral Aneurysm; Amnesia

Summary: to clarify whether amnesia after treatment of anterior communicating aneurysm (acoa)is related to infarcts caused by occlusion or damage of the perforating artery of the acoa, we used 3.0-t 3d high resolution mr imaging to identify and localize infarcts in patients with amnesia following treatment of acoa aneurysm.

cohort register is made by experienced neuropsychologists in our institute. mr imaging and data storage is in the department of diagnostic radiology of our institute. mr images are evaluated by two neuroradiologists using a work station.

Eligibility criteria:
inclusion criteria: clinical diagnosis of amnesia exclusion criteria: severe decreased intellectual function